Qualifications
Must-Have
- Bachelor’s Degree
- 3+ years of experience
- Prior relevant leadership experience in a regulated manufacturing operations environment
- Working knowledge of Upstream/Downstream Current Good Manufacturing Practices (cGMP) manufacturing operations
- Strong people management experience
- Excellent leadership, communication, and interpersonal skills
- Ability to work in a dynamic, fast-paced and goal-driven environment with strong decision-making capability
Nice-to-Have
- Master’s degree
- Relevant pharmaceutical industry experience
Knowledge and Skill
Technical Skills:
- Basic knowledge of pharmaceutical industries, machines cleaning operation and maintenance
- Understand workplace safety and related procedures (First aid)
- Basic knowledge on pharmaceutical industries and its standards
- Good communication skills
- Knowledge on basic troubleshooting
Standards, Process, and Policies:
- Basic understanding of cGMP, global quality standards, and data integrity
Behavioral/Other Skills:
- Attention to detail
- Willingness to take direction and adhere to procedures
- Basic understanding of hygiene and clean room work culture
- Proper utilization of personal protective equipment during activities
Responsibilities
Equipment Installation and Qualification:
- Participate in the installation, site acceptance test, installation qualification, operation qualification, process qualification, and re-qualification of equipment in the respective functional area
- Participate in the execution of equipment qualification, performance verification, and process validation
Ongoing Operation:
- Manage multiple projects and work activities (timelines, work plans, deliverables) within the team
- Support development of SMART objectives for the full team
- Participate in Pfizer network programs to ensure best practice sharing
- Assist with the development of your unit from commissioning through to start-up, validation, and Current Good Manufacturing Practices (part of GxP) operations
- Lead System Application & Products Materials process for Shift
- Perform quality checks on processing activities and process confirmations of Integrated Manufacturing Excellence (IMEx) elements
- Drive implementation and embedding of Lean tools in the area
- Act as an interface between management team and functional team
- Support shift colleagues’ individual development plan
- Ensure contingent staff are managed appropriately in terms of performance and training
Quality Management and Compliance:
- Follow cGMP and safety at all stages of manufacturing activity
- Compliance with Pfizer integrity principles at all stages of manufacturing
- Participate in internal and external (regulatory and non-regulatory) audits
Documentation:
- Prepare the daily activity report
- Complete the documents online as per cGMP and GDP
- Preparation of user requirement specification (URS), standard operating procedures, change control forms, and corrective action and preventative action and support investigation
- Responsible for protocols preparation, execution, completion, review and submission, and retrieval to document cell and validation as per requirement
Training:
- Attend training for all the applicable procedures as per the schedule before performing the job
- Should be able to provide training to the trainees
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.